Gene probes and enzyme assays soon may become the newest equipment in the employe gym.
One Washington company is working to combine these and other new tools of microbiology to calculate people's health risks and map out ways to avoid health problems through changes in life style.
Just as blood pressure and cholesterol level information is used today to gauge a person's risk of heart disease, Focus Technologies Inc. hopes to use new "biomarkers" -- health signals contained in genes, enzymes and antibodies -- to measure other risks.
Scientists have made dramatic advances in recent years in pinpointing the genes related to certain health problems. Focus Technologies hopes to take this work a step further by combining gene markers with other new biomarkers detected in blood and urine samples and correlating the information on a computer to draw comprehensive health-risk portraits.
Focus contends that such high-tech, personalized risk assessments can motivate people to lead healthier lives and help companies hold down their health care costs.
The company also hopes such information will strengthen a person's will to quit smoking, eat a better diet and make other prescribed health-improving changes in life style.
Focus, working with the Equitable Life Assurance Society, plans to begin testing this concept this summer in a pilot program for Equitable employes and group insurance clients.
Called "Biomark," the program comes at a time when hundreds of companies are investing in wellness programs designed to educate employes about nutrition, and to help them quit smoking, lose weight or manage stress. "Insurance companies are in up to their necks in wellness," said Ben Isaacs, a spokesman for the Health Insurance Association of America. "If Biomark does what they say it does, it will be an entree into the 21st century."
Biomark also comes at a time of rising concern about the potential misuse of the information it could provide. Some observers worry that details about a person's genes or vulnerability to disease could be used by companies to screen new hires or by insurers to deny coverage. Some public health experts worry that even a company with good intentions might mishandle such information in a way that could cause needless alarm about one possible risk, or undue complacency about another.
And some public health officials express doubts about the link between improved information and the willpower to make changes in personal habits, citing cigarette smoking as an example of human willingness to accept health risks.
Focus and Equitable say their project reflects the cutting edge in preventive medicine and health care cost management.
"This is the second generation in health promotion programs," said Steven M. Putterman, assistant vice president for strategic planning at Equitable Group and Health Insurance Co., a division of Equitable Life Assurance. "By marrying existing technology with existing health promotion activities, we expect a tremendous synergy which should help motivate people to change behavior patterns."
"The ultimate form of cost containment is the prevention of disease," said Sanford D. Greenberg, Focus chairman and chief executive.
Specialists in the area of public health and preventive medicine say the use of new biotech tools would be an extension of risk evaluation programs used to measure blood pressure, blood sugar and cholesterol. This data is combined, often by computer, with information such as weight, sex, age and family history to produce an analysis of the risk of heart, lung and other diseases. A physician then can advise a patient to cut down on certain foods, get more exercise or take other steps to reduce risk.
Focus contends that the technology exists today to make much more precise measurements of risk. For example, blood pressure and cholesterol levels are used today to gauge a person's risk of atherosclerosis, a clogging and thickening of the inner artery walls that can lead to heart attack and stroke. These measurements often do not indicate a problem until middle age, after the disease has developed. But the risk of developing atherosclerosis could be detected much earlier by identifiying a gene linked to the disease, said Focus Managing Director Nelson M. Schneider, a former biotechnology analyst for E. F. Hutton Group Inc.
A gene probe -- a piece of genetic material that links only with a matching piece -- exists that can identify a gene that indicates an inability to break down cholesterol, Schneider said. "So a person with that gene should really avoid cholesterol. Moderate levels could be life-threatening," he said.
Antibodies Give Health Clues
Antibodies can be used to identify a condition characterized by excess iron in the blood, a problem few people are tested for that can lead to liver or kidney disease, Schneider said. A person with this condition might be advised to avoid iron supplements, calves' liver and drinking water with heavy mineral content, and would have an extra reason to cut down on alcohol, which also can contribute to liver disease.
Another test, or assay, can measure the presence of an enzyme that plays an important role in protecting the inner lining of the lung. A person lacking sufficient amounts of that enzyme would have a higher than normal risk of lung damage from smoking or inhaling other people's smoke.
Focus executives say these and other biomarkers exist already, but are scattered across the country in various company and university laboratories. And more markers are being discovered; for example, last week medical researchers reported the development of a test to identify a genetic defect related to the regulation of cholesterol levels.
Focus plans to license different markers and pull them together into one package, while financing research to develop new tools. "Now we have a Model-T Ford compared to the horse and buggy," Schneider said. "In a few years we'll have a Porsche."
Company officials decline to specify which markers they may use and how they work, because they are in the process of deciding which ones to use and negotiating licensing agreements.
Schneider said they are studying 187 markers that indicate the risk of getting 160 different diseases and are conducting cost-benefit analyses on which to use. A marker for an extremely rare disorder, or a marker that required complicated and expensive processing for a minor problem, would not be cost-effective, Schneider said.
The pilot program will include about 25 to 30 risk markers for the same number of diseases. Biomark will include only prognostic indicators of risk, not diagnostic tests, nor any markers for unavoidable genetic diseases such as Huntington's disease or muscular dystrophy, Schneider said.
The key to the program is the belief that better information motivates behavior changes, an assumption debated by some behavioral and preventive medicine specialists.
"The concept seems sensible, but we really don't have proof," said William B. Kannel, chief of the section on preventive medicine and epidemiology at Boston University, who uses risk evaluations to treat his patients. "I hope they will work."
Knowledge Affects Life Style
One positive sign is the 33 percent decline in heart disease since 1968, Kannel said. About 60 percent of that drop is attributed to changes in life style, including decreases in the consumption of fat, eggs, and red meat, a decline in smoking, the jogging craze and a national campaign to measure blood pressure levels.
On the other hand, the American Lung Association estimates that 51 million people smoke -- despite the warnings, the efforts to quit, and the 350,000 deaths per year attributed to smoking-related diseases.
"There is some indication that changes in life style can improve health, but it is hard to say whether risk assessments motivate people to change," Kannel said.
Even if the concept works, it raises the issue of how such personal information could be misused. An employer might not want to hire someone with a high risk of heart and lung diseases. An insurance company might want to charge higher premiums or refuse coverage when risks are high.
"It's a very interesting area of research which is inevitably going to go on, but there is no guarantee the information will be used well," said Willis B. Goldbeck, president of the Washington Business Group on Health. "Look at how the AIDS test is being used to destroy lives, keep kids out of school and keep people out of work."
Focus officials say participation in the program will be voluntary, and the company will share personal health risk information only with the employe and not with employers or the insurance company. If the employe consents, the information will be provided to his or her physician.
They also note that about 90 percent of the nation's private health insurance is obtained through group policies, which automatically enroll a person along with his or her dependents. The other 10 percent normally submit to medical evaluations to obtain individual insurance.
Risk assessment methods now available are not commonly used to screen new hires, Schneider adds.
Improving Actuarial Assessment
Biomarkers could mean "a generational leap in the quality of actuarial assessment," Goldbeck said. "I'm not saying don't proceed, but proceed with a healthy dose of wonder and scrutiny."
"People will become accustomed to this as they are to blood pressure tests," Greenberg said.
Other health experts worry that the information could be mishandled in other ways, alarming people with the notion that they have "defective" genes or misleading smokers into thinking their enzymes allow them to smoke safely.
Several emphasize that to be effective, any appraisal of risk must be accompanied with programs to support an individual's efforts to reduce that risk, such as nutrition, weight reduction, smoking cessation and stress management programs.
"You can't stop at identifying risk," said Dindy Weinstein, executive director of the National Capital Area Health Care Coalition. "The important thing is to follow up with ways to remove them from risk."
Focus was founded last year by TEI Medical, a District-based limited partnership created to launch and manage new companies to use emerging technologies to improve health care and reduce its costs.
TEI has created one other company, Health Care Systems Inc., founded in 1983, which has refined and marketed a health monitoring program that last year won a cost-containment award from the National Capital Area Health Care Coalition.
Equitable has committed more than $1 million to develop the Biomark program, and more than $2 million to develop the Health Care Systems monitoring program.